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NEDOCROMIL SODIUM EYE DROPS 2%

Active substance(s): NEDOCROMIL SODIUM

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THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

RAPITIL® EYE DROPS/
NEDOCROMIL SODIUM EYE DROPS 2% w/v
(nedocromil sodium)
Patient Information Leaflet

4. Possible side effects
5. How to store Rapitil Eye Drops
6. Further information

1. WHAT RAPITIL EYE DROPS ARE AND WHAT THEY ARE USED FOR
What Rapitil Eye Drops are
Rapitil Eye Drops contain a medicine called nedocromil sodium. This belongs to a group of medicines called
anti-allergics.
How Rapitil Eye Drops work
It works by stopping the release of the natural substances in your eyes that can lead to an allergic reaction.



‘Perennial allergic conjunctivitis’ in adults only: This type of allergy can happen at any time of
the year and is often caused by animal fur or house dust mites. Signs include itchy, watery, red or
inflamed eyes and puffy eyelids.



‘Seasonal allergic conjunctivitis’ in adults and children: This type of allergy, such as hay fever,
can be caused by different pollens in different seasons of the year. Signs include itchy, watery, red
or inflamed eyes and puffy eyelids.



‘Vernal kerato conjunctivitis’ in adults and children: This is a more severe type of allergy. Signs
include bumps inside the upper eyelid, sensitivity to light and severe itching

WARNING!

What Rapitil Eye Drops can be used for
Stopping, treating and relieving the symptoms of ‘allergic conjunctivitis’ (inflammation of parts of the eye).
Rapitil Eye Drops can be used for three types of allergic conjunctivitis:

DATE:

2. BEFORE YOU USE RAPITIL EYE DROPS
Do not use this medicine and tell your doctor or pharmacist if:
• You are allergic (hypersensitive) to nedocromil sodium, or any of the other ingredients of Rapitil Eye
Drops (listed in Section 6 overleaf)
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling of your lips,
face, throat or tongue or around the eyes
Do not use this medicine if the above applies to you. If you are not sure, talk to your doctor or pharmacist
before using Rapitil Eye Drops.

Driving and using machines
Your eyesight may be affected after using this medicine. If this happens, do not drive or use any tools or
machines until you can see clearly.
TVT CHECKED

Important information about some of the ingredients of Rapitil Eye Drops
Rapitil Eye Drops contain benzalkonium chloride. This may cause your eyes to become irritated. It may also
change the colour of your contact lenses.
3. HOW TO USE RAPITIL EYE DROPS
Always use Rapitil Eye Drops exactly as your doctor or pharmacist has told you. You should check with your
doctor or pharmacist if you are not sure.
TO UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

25/02/14
DATE OF PROOF:

If you are breast-feeding or planning to breast-feed, talk to your doctor or pharmacist before taking or using
any medicine.

6464/2193A

DATE:

DT
ARTWORKER:

Pregnancy and breast-feeding
Talk to your doctor before using this medicine if you are pregnant, might become pregnant or think you may
be pregnant.

CODE:

Q.A.
APPROVED:
05-0440

CUSTOMER: Waymade
PRODUCT: Rapitil eye drops

PRE-PRESS NO.:

Take special care with Rapitil Eye Drops if:
• You wear soft contact lenses. You should not wear soft contact lenses while using these drops
If you are not sure if this applies to you, talk to your doctor or pharmacist before using Rapitil Eye Drops.

Using this medicine
• If you wear hard or gas-permeable contact lenses, you should take them out while you use the eye
drops. You should wait 15 minutes before you put the contact lenses back in
• If you need to use more than one type of eye medicine, the medicines must be used at least 5
minutes apart. Eye ointments should be used last.
• If you feel the effect of your medicine is too weak or too strong, do not change the dose yourself, but
ask your doctor or pharmacist
How to use this medicine
• Wash your hands
• Remove the cap from the bottle
• Tilt your head back
• Squeeze one or two drops inside the lower lid without touching your eye
• Close your eye
• Wipe away any excess liquid from the eyes with a clean tissue
• Always put the cap back on the bottle as soon as you have used it
• Repeat in the other eye as needed

Colour
Swatch

Black

WARNING!

In this leaflet:
1. What Rapitil Eye Drops are and what they are used for
2. Before you use Rapitil Eye Drops
3. How to use Rapitil Eye Drops

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

Notes:

CUSTOMER
APPROVED:

This product is known by the above names, but will usually be referred to as Rapitil Eye Drops throughout
this leaflet.
Read all of this leaflet carefully before you start using this medicine
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their
symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell
your doctor or pharmacist. See section 4.

PROOF HISTORY:
v.1 - waymade - 25/02/14

Leaflet Flat Size = 148 x 317

27mm

THE COLOURS SHOWN ON THIS PROOF ARE FOR GENERAL REPRESENTATION PURPOSES ONLY. THEY ARE NOT ACCURATE AND MUST NOT BE
USED AS A COLOUR MATCH FOR THE FINISHED JOB. PLEASE REFER TO THE PANTONE COLOUR GUIDES FOR ACCURATE COLOUR REFERENCES.

27mm

How much to use
Adults, Elderly and Children aged 6 years and over
Seasonal allergic conjunctivitis:
• One drop into each eye twice each day
• This can be increased to four times each day if needed
• Do not use for more than 12 weeks

ARIAL REGULAR FONT SIZE 8
ARIAL BOLD
FONT SIZE 8
BRIDGED TO
SERETIDE 6464/2342 6464/2343

Children under 6 years
This medicine is not recommended for children aged less than 6 years.
If you take more Rapitil Eye Drops than you should
If you use more Rapitil Eye Drops than you should, talk to your doctor or go to a hospital straight away.
Remember to take any medicine that is left with you so the doctor knows what you have taken.
If you forget to use Rapitil Eye Drops
If you forget a dose, use your drops as soon as you remember. However, if it is nearly time for your next
dose, skip the missed dose. Do not use a double dose to make up for a forgotten dose.
If you stop using Rapitil Eye Drops
Keep using the eye drops for as long as your doctor or pharmacist advises you. If you stop using Rapitil Eye
drops too early, your allergy symptoms may come back.
If you have any further questions on the use of this product, ask your doctor or pharmacist.

WARNING!

4. POSSIBLE SIDE EFFECTS
Like all medicines, Rapitil Eye Drops can cause side effects, although not everybody gets them.
Stop using Rapitil Eye Drops and see a doctor as soon as possible if:
• The itching, redness or swelling gets worse. You may be allergic to these drops

Common (affects 1 to 10 people in a 100)
• Stinging or burning in your eyes or blurring of eyesight. This should only last for a short time and occurs
immediately after using the eye drops
• Change in the way things taste
Uncommon (affects 1 to 10 people in a 1,000)
• Mild eye irritation

TO UK PIL DATED OCTOBER 2013
REPORTING OF SIDE EFFECTS

6464/2193A

DATE:

DT

25/02/14

ARTWORKER:

DATE OF PROOF:

5. HOW TO STORE RAPITIL EYE DROPS
• Do not use after the expiry date printed on the carton or bottle label. The expiry date refers to the last day of
that month.
• Rapitil eye drops/Nedocromil sodium eye drops 2% w/v should not be stored above 25°C. Keep out of direct
sunlight.
• You should discard the contents four weeks after opening. Rapitil Eye Drops are sterile when you buy them,
so you must not keep them for more than four weeks after opening the bottle.
• Replace the cap securely after each use to avoid the risk of contamination.
• Keep all medicines out of the sight and reach of children.
• If your doctor tells you to stop using the drops, please take it back to the pharmacist for safe disposal. Only
keep the drops if your doctor tells you to.
• Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These measures will help to protect the environment.
• If your drops become discoloured or cloudy you should ask your doctor or pharmacist for advice.

CODE:

Q.A.
APPROVED:
05-0440

CUSTOMER: Waymade
PRODUCT: Rapitil eye drops

PRE-PRESS NO.:

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not
listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this medicine.

6. FURTHER INFORMATION
What Rapitil Eye Drops contain
Your medicine is called Rapitil eye drops /Nedocromil sodium eye drops 2% w/v. It contains the active
ingredient, Nedocromil sodium 2% w/v.
Rapitil eye drops/Nedocromil sodium eye drops 2% w/v also contain the following inactive ingredients:
benzalkonium chloride (as preservative), sodium chloride, disodium edetate and purified water.
What Rapitil Eye Drops look like and contents of the pack
Rapitil eye drops/Nedocromil sodium eye drops 2% w/v are available as a pale yellow liquid in a 5ml plastic
dropper bottle.
POM

PL No: 6464/2193

This product is manufactured by Sanofi Winthrop Industrie, Boulevard Industriel, zone Industrielle, 76580 Le
Trait, France and is procured from within the EU and repackaged by the Product Licence holder:
Waymade plc, Miles Gray Road, Basildon, Essex SS14 3FR
Leaflet revision and issue date (Ref.) 25.02.2014
Rapitil is a registered trademark of Fisons Limited

Colour
Swatch

Black

WARNING!

DATE:

CUSTOMER
APPROVED:

Talk to your doctor or pharmacist if any of the side effects gets serious or lasts longer than a few
days, or if you notice any side effects not listed in this leaflet:

WE CANNOT ACCEPT RESPONSIBILITY FOR ANY ERRORS IN THIS PROOF AFTER APPROVAL. THE ARTWORK RECEIVED HAS BEEN SIGNIFICANTLY
ADJUSTED, REVISED OR RESET BY US FROM DISK OR HARD COPY. WHILST WE TAKE EXTREME CARE AT ALL TIMES TO ENSURE ACCURACY, THE FINAL RESPONSIBILITY
MUST BE TAKEN BY OUR CUSTOMER. IF YOU SIGN THIS PROOF YOU ARE SIGNIFYING FULL APPROVAL OF DESIGN AND TEXT.

Notes:

Adults and the Elderly only
Perennial allergic conjunctivitis:
• One drop into each eye twice each day
• This can be increased to four times each day if needed
• Use the drops regularly

PROOF HISTORY:
v.1 - waymade - 25/02/14

Leaflet Flat Size = 148 x 317

Vernal kerato-conjunctivitis
• One drop into each eye four times each day

Expand view ⇕

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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